H1N1: The Report Card

READER’S DIGEST: What have been our biggest successes and failures?SECRETARY KATHLEEN SEBELIUS: We went from identifying the virus to producing the first vaccine in less than six months. That’s pretty unheard of! We’ve been enormously successful at distributing the vaccine—over 60 million people have been vaccinated so far. With childhood vaccinations, we have 40,000 sites for distribution. We went from that to over 100,000 sites to try to get the vaccine to where states identified it was most needed for priority populations. That has gone extremely well. The production glitches have been a bit frustrating.

RD: Why didn’t we learn about the problems growing the vaccine until October?

KS: Well, I think in July there was a downgrade in the numbers that were anticipated. So that was really the first opportunity to take a look at the growth rate. And I think up until then there had been discussion of over 100 million doses being available. Starting in July, that was cut by almost two thirds. It was lowered to about 50 million. And it really wasn’t until early October that the manufacturers then revised those numbers even further.

RD: I was curious what the manufacturers say as to why it took them so long to be able to give you the numbers.

KS: You know, I don’t know. I think you’re going to have to ask them. But there certainly was reporting along the way. And what we tried to do was share with the public what we were learning. We always knew that there wouldn’t be enough supply as it came off the line. Once the advisory committee made its recommendations, which included up to 160 million people—I mean, it was clear that it would take some time to reach that level of penetration. But I think that when schools began to be back in session in mid-August, and the disease began to spike, the shortage seemed even more pronounced.

RD: Do you think the decision not to use adjuvanted vaccine should be revisited? [NOTE: A vaccine adjuvant is a substance that’s added to increase the response of the immune system. Because the vaccine is more powerful, less of it is needed. However, there have been relatively few studies on adjuvanted vaccines.]

KS: Well, the dilemma that we were in here in the United States is that an adjuvanted vaccine had not been licensed for use. There had never been clinical trials in children. And what we were looking for was the safest and fastest pathway to a vaccination program. So it made sense for us to use the technology that was tried and true, and to use the pre-existing licenses that were already in place for seasonal flu vaccines. But I think one of the lessons that will be learned from H1N1 is: What are the clinical results of vaccinations with adjuvants now going on all around the world? Nobody—including countries in Europe, which have used adjuvanted vaccines for adults—have ever used adjuvanted vaccine for children.

RD: Right, right.

KS: So we’ll have an opportunity to look at that. But, you know, given the hesitation of some people about vaccinations anyway, to suddenly announce we were going to launch a major program to vaccinate children with an ingredient that had never been tried before—I’m afraid that would have raised some huge barriers.

RD: You recently took part in the ribbon-cutting for a new Holly Springs, N.C., factory that will produce cell culture-based flu vaccines as early as 2012. Do you think cell culture vaccines will help?

KS:That plant is a big deal for two reasons, not the least of which is that it brings manufacturing capacity back to the United States. That’s a significant step forward—we’re not so reliant on production elsewhere. During the current epidemic, two companies had to fill orders in their own countries before they could make the vaccines available to us. Secondly, cell-based culture doesn’t necessarily speed the growth time, but it is more reliable. Once the growth is there, you have yield that is much more stable than with egg-based technology. It isn’t a silver bullet, but egg-based technology is 50 years old and we need to get to a variety of approaches that could be used in the future. So the investments need to continue: What are the alternative growth strategies? What else should we be looking at?

RD: We’ve all heard about healthy people who come down with H1N1 and are dead within a few days. Are you satisfied with the medical response to this disease?

KS: Well, the data is puzzling, and I think a bit troubling, in that we know that about a third of the kids who have been seriously ill or died do not have underlying health conditions. And it’s the same with 25-year-olds and up; we don’t still quite understand why those over 65 seem to have a lot of resistance to this particular virus. I think it’s going to take a while for the scientists to figure this out—what exactly is going on with this disease. While there have been some recent reports that the vast majority of cases have been relatively mild, what the scientists are quick to say is that the severe cases are more severe than many of them have ever seen. I mean, the penetration is more rapid, it’s more devastating, it fills the lungs. So, yes, it’s pretty mild most of the time, but when it’s bad it’s really bad. But what exactly it is that triggers that, we don’t know. The group that has underlying health conditions isn’t so hard to understand. But the group that does not have underlying health conditions and moves from total health to a ventilator in two days, which has been the case too many times with younger people—that, I think, still needs to be understood.

RD: As this was being rolled out we heard about strains on public health departments. Has that affected the government’s response?

KS: Every state in the country is dealing with fewer personnel than they would have had if this had happened three years ago. That lack of resources means people have had to add more duties with fewer folks. But our coordination has worked tremendously well, and it fact we have learned a lot that will prepare us for the future, whether for the next pandemic or for other kinds of public health emergencies.

RD:What can be done about public mistrust of vaccines?

KS:There are groups out there that insist that vaccines are responsible for a variety of problems despite all scientific evidence to the contrary. We have reached out to media outlets to try to get them to not give the views of these people equal weight in their reporting to what science has shown and continues to show about the safety of vaccines.

RD: I’ll just close by asking if there’s something you would like to add.

KS: Well, knowing that this is going to be a February article, I think one of our challenges is to make sure that people understand that what we saw this fall was a second wave of H1N1. We have an opportunity to get out ahead of what easily could be a third wave. There are lot of scientists who feel that if we’re successful, if we continue the vaccination program into the new year and get as many people vaccinated as possible, we really might avert what various experts believe may be a more vicious strain in the later winter months when flu season is really underway.

RD: So a lot of people think that it could be worse, the third wave?

KS: In some other epidemics, there was a spike and then a milder spike, and then a big jump. And nobody knows if that might be the pattern with this virus. But there’s a window where we’re going to have vaccine and hopefully the disease will have peaked. And that gives us an opportunity to continue to reach out.